Safety, immunogenicity, and efficacy of a Clostridioides difficile toxoid vaccine candidate: a phase 3 multicentre, observer-blind, randomised, controlled trial
RCT (n=9,302) was terminated early due to futility as the vaccine did not reduce C difficile infections vs placebo when used in patients considered to be at increased risk (0.29 vs 0.28 infections per 100 person years). Clinical development of this vaccine has stopped.
Source:
The Lancet Infectious Diseases
SPS commentary:
A related commentary confirms the disappointment with these results and states that future studies of primary C difficile infection prevention should include patients at the highest risk of C difficile infection, including those who are aged 50 years and older, have received antibiotics within 3 months of enrolment, and have at least one comorbidity (such as chronic kidney disease or diabetes), to enable a bigger effect size of the primary outcome.